2022年12月1日 · Herein we describe a platform method to study the charge heterogeneity of adeno-associated virus (AAV) capsid proteins. The method, based on imaged capillary isoelectric focusing (icIEF) with native fluorescence imaging detection, was validated, and can be used as an identity assay and stability indication assay.

2023年6月8日 · Here, we present a robust icIEF method leveraging simplified one-step sample preparation to profile charge variants of AAV VPs. This rapid capillary assay is suitable for monitoring charge heterogeneity during manufacturing and storage of AAV products for the purposes of product release and stability.

2023年3月10日 · In the present study, we developed simple, one-step sample preparation and charge-based VP separation using imaged capillary isoelectric focusing (icIEF) for monitoring AAV products.

2023年5月3日 · In this study, we describe an icIEF immunoassay method for AAV analysis that is 90 times more sensitive than native fluorescence icIEF. This icIEF immunoassay provides AAV stability monitoring, where changes in individual capsid protein charge heterogeneity can be observed in response to heat stress.

By leveraging different primary antibodies, the icIEF immunoassay provides additional selectivity and affords a detailed characterization of individual AAV capsid proteins. In this study, we describe an icIEF immunoassay method for AAV analysis that is 90 times more sensitive than native fluorescence icIEF.

Utilizing the MauriceFlex system, we developed an approach for the separation of charged species from AAV capsid viral proteins (VP) by icIEF and subsequent characterization by liquid chromatography and mass spectrometry (LC-MS).

The study described the development of an imaged cIEF (icIEF) platform method on the MauriceTM system for charge heterogeneity analysis of AAV capsid proteins, which in turn provided critical insights into post-translational modifications (PTMs) and associated decrease in potency as a stability indicating assay.

Imaged capillary isoelectric focusing (icIEF) and capillary electrophoresis sodium dodecyl sulfate (CE-SDS) are two powerful methods to respectively characterize charge heterogeneity and purity, but traditionally two separate platforms are required to run these methods.

2022年5月1日 · Capillary isoelectric focusing with whole-column imaging detection (icIEF) technology is now the mainstream technology to perform analytical isoelectric focusing analysis in pharmaceutical industry.

2023年6月8日 · Here, we present a robust icIEF method leveraging simplified one-step sample preparation to profile charge variants of AAV VPs. This rapid capillary assay is suitable for monitoring charge heterogeneity during manufacturing and storage of AAV products for the purposes of product release and stability.